Efficacy and Safety Evaluation of Osilodrostat in Cushing's Disease
Brief Summary
The purpose of this study was to confirm efficacy and safety of osilodrostat for the treatment of patients with Cushing's disease who are candidates for medical therapy.
Detailed Description
The study LCI699C2302 (LINC-4) is a multi-center, randomized, double-blind study to evaluate the safety and efficacy of osilodrostat in patients with Cushing's disease. Enrolled patients were initially randomized to either osilodrostat or placebo, in a 2:1 ratio, for a 12-week double-blind period (Period 1). Randomization was stratified by history of pituitary radiation. After Week 12, all patients received open-label osilodrostat until the end of the Core phase at Week 48 (Period 2). After Week 48, patients could join an optional 48 week extension period.
Interventions
Primary Outcomes
Trial Information
NCT02697734
Completed
INTERVENTIONAL
PHASE3
Novartis Pharmaceuticals
December 15, 2025